MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE RENT; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number L201-90411

Device Problems Pumping Stopped (1503); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2023

Event Type  malfunction  

Event Description

Related manufacturer reference number: 3003306248-2023-05061 (mag monitor set).Related manufacturer reference number: 3003306248-2023-05059 (centrimag motor).Related manufacturer reference number: 3003306248-2023-05060 (centrimag motor).Related manufacturer reference number: 3003306248-2023-05074 (console).It was reported that while supporting a biventricular assist device (bivad) patient in the operating room (or), the patient experienced simultaneous pump stoppages as both centrimag consoles went to zero rpm and zero flow.Several successive beeps sounded, and it was noted that the beeps sounded like the emergency stop button had been pushed, although no one had done so.The rpms of both systems were manually increased immediately, and flow was re-established to the patient.Both consoles were attached to centrimag mag monitor at the time of the event.It was noted that power strips, strong magnets, cell phones, fluoroscopes, and bluetooth devices were not used in close proximity and that both consoles were plugged into a red emergency hospital ac power outlet.It was advised that the mag monitor be disconnected from both consoles so that the consoles could be interfaced directly, and no further rpm disruptions were reported after disconnecting.There was no adverse patient consequence, and it was also noted that these were abbott rented systems.Log files for both consoles were sent in for evaluation.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturers investigation is complete.

Manufacturer Narrative

Section d4: expiration date was inadvertently added in the initial report and is not applicable for this device.Manufacturer's investigation conclusion: the centrimag console was returned for evaluation following the reported event of the pump speed dropping to zero revolutions per minute.However, it was determined that the returned centrimag console was unrelated to the cause of the event.The returned centrimag console was functionally tested by service depot and unit operated as intended throughout all testing.The serviced and tested unit was returned to the rental pool after passing all tests per procedure.It was revealed that the root cause of the reported event was related to the returned centrimag motors.The motors¿ evaluation along with the log files associated with this event have been addressed via the motor investigations (mfr.Report # 3003306248-2023-05059 and 3003306248-2023-05060).The device history records were reviewed and the records revealed that the centrimag console was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual (rev.M) section 10 ¿ ¿emergencies/troubleshooting¿ provides instructions for operation when there is a need to exchange the main console or motor with a backup console or motor.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.The 2nd generation centrimag system operating manual (rev.M) section 12.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), including alarms related to the system stopping, and the appropriate actions to take if the issue does not resolve.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE RENT
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17725655
• MDR Text Key: 323821213
• Report Number: 3003306248-2023-05075
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L201-90411
• Device Lot Number: 8611615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male